Alcohol
A reaction characterized by flushing, sweating, headache, and tachycardia has been reported when alcohol was ingested during and as late as the fifth day after cefoperazone administration. A similar reaction has been reported with certain other cephalosporins and patients should be cautioned concerning ingestion of alcoholic beverages in conjunction with administration of sulbactam/cefoperazone. For patients requiring artificial feeding orally or parenterally, solutions containing ethanol should be avoided.
Drug Laboratory Test Interactions
A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solution.
Pregnancy and Lactation
Usage During Pregnancy
Reproduction studies have been performed in rats at doses up to 10 times the human dose and have revealed no evidence of impaired fertility and no teratological findings. Sulbactam and cefoperazone cross the placental barrier. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Usage in Nursing Mothers
Only small quantities of sulbactam and cefoperazone are excreted in human milk. Although both drugs pass poorly into breast milk of nursing mothers, caution should be exercised when sulbactam/cefoperazone is administered to a nursing mother.
Effects on Ability to Drive and Use Machines
Clinical experience with sulbactam/cefoperazone indicates that it is unlikely to impair a patient’s ability to drive or use machinery.
Undesirable Effects
Sulbactam/cefoperazone is generally well tolerated. The majority of adverse events are of mild or moderate severity and are tolerated with continued treatment. In pooled clinical trial data from comparative and non-comparative studies in approximately 2,500 patients the following was observed:
Gastrointestinal: As with other antibiotics, the most frequent side effects observed with sulbactam/cefoperazone have been gastrointestinal. Diarrhea/loose stools 3.9% have been reported most frequently followed by nausea and vomiting 0.6%.
Dermatologic Reactions: As with all penicillins and cephalosporins, hypersensitivity manifested by maculopapular rash 0.6% and urticaria .08% has been reported. These reactions are more likely to occur in patients with a history of allergies, particularly to penicillin.
Hematology: Slight decreases in neutrophils 0.4% (5/1131) have been reported. As with other beta lactam antibiotics, reversible neutropenia 0.5% (9/1696) may occur with prolonged administration. Some individuals have developed a positive direct Coombs test 5.5% (15/269) during treatment. Decreased hemoglobin 0.9% (13/1416) or hematocrit 0.9% (13/1409) have been reported, which is consistent with published literature on cephalosporins. Transient eosinophilia 3.5% (40/1130) and thrombocytopenia 0.8% (11/1414) have occurred, and hypo prothrombinemia 3.8% (10/262) has been reported.
Miscellaneous: Headache .04%, fever 0.5%, injection pain .08%, and chills .04%.
Laboratory Abnormalities: Transient elevations of liver function tests, SGOT 5.7% (94/1638), SGPT 6.2% (95/1529), alkaline phosphatase 2.4% (37/1518) and bilirubin 1.2% (12/1040) levels, have been noted.
Local Reactions: Sulbactam/cefoperazone is well tolerated following intramuscular administration. Occasionally, transient pain may follow administration by this route. As with other cephalosporins and penicillins, when sulbactam/cefoperazone is administered by an intravenous catheter some patients may develop phlebitis 0.1% at the infusion site.
In post-marketing experience the following additional undesirable effects have been reported:
General: anaphylactoid reaction (including shock) Cardiovascular: hypotension, Gastrointestinal: pseudomembranous colitis, Hematopoietic: leucopenia, Skin/Appendages: pruritus, Stevens Johnson Syndrome, Urinary: hematuria, and Vascular: vasculitis.
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